Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT ID: NCT01788046
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
515 participants
INTERVENTIONAL
2013-03-12
2014-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Placebo
Administered intravenously (IV) three times per week.
Etelcalcetide
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
Etelcalcetide
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
Interventions
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Etelcalcetide
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
Placebo
Administered intravenously (IV) three times per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is 18 years of age or older.
* Subject agrees to not participate in another study of an investigational agent during the study.
* Subject must be receiving hemodialysis 3 times weekly for at least 3 months
Exclusion Criteria
* Other investigational procedures while participating in this study are excluded.
* Anticipated or scheduled parathyroidectomy during the study period.
* Subject has received a parathyroidectomy within 3 months prior to dosing.
* Anticipated or scheduled kidney transplant during the study period.
* Subject has known sensitivity to any of the products or components to be administered during dosing.
* Subject has participated in a prior clinical trial of AMG 416
* Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
* Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Mobile, Alabama, United States
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Azusa, California, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Fairfield, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Norwalk, California, United States
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Riverside, California, United States
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Simi Valley, California, United States
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Denver, Colorado, United States
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Stamford, Connecticut, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Augusta, Georgia, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Merrillville, Indiana, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Bethesda, Maryland, United States
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Ft. Washington, Maryland, United States
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Detroit, Michigan, United States
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Brookhaven, Mississippi, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Eatontown, New Jersey, United States
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Brooklyn, New York, United States
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Fresh Meadows, New York, United States
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Great Neck, New York, United States
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Charlotte, North Carolina, United States
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New Bern, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Arlington, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Rutland, Vermont, United States
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Alexandria, Virginia, United States
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Morgantown, West Virginia, United States
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Westmead, New South Wales, Australia
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Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Bonheiden, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Tournai, , Belgium
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Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Nový Jičín, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Ústí nad Orlicí, , Czechia
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Bordeaux, , France
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Caen, , France
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Grenoble, , France
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Marseille, , France
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Marseille, , France
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Perpignan, , France
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Erfurt, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Esztergom, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Zalaegerszeg, , Hungary
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Ancona, , Italy
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Lecco, , Italy
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Milan, , Italy
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Quartu Sant'Elena CA, , Italy
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Amsterdam, , Netherlands
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Enschede, , Netherlands
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Rotterdam, , Netherlands
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Venlo, , Netherlands
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Gdansk, , Poland
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Golub-Dobrzyń, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Rybnik, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Córdoba, Andalusia, Spain
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Granada, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Majadahonda, Madrid, Spain
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Karlstad, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
Countries
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References
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Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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KAI-4169-007
Identifier Type: OTHER
Identifier Source: secondary_id
2012-002806-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120230
Identifier Type: -
Identifier Source: org_study_id
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